The following data is part of a premarket notification filed by Laborie Medical Technologies, Ltd. with the FDA for Piper, Model Number Uds-piperb.
| Device ID | K951805 |
| 510k Number | K951805 |
| Device Name: | PIPER, MODEL NUMBER UDS-PIPERB |
| Classification | Device, Cystometric, Hydraulic |
| Applicant | LABORIE MEDICAL TECHNOLOGIES, LTD. 6415 NORTHWEST DR. UNIT 11 Mississauga (ontario), CA L4v 1x1 |
| Contact | Fred Buffa |
| Correspondent | Fred Buffa LABORIE MEDICAL TECHNOLOGIES, LTD. 6415 NORTHWEST DR. UNIT 11 Mississauga (ontario), CA L4v 1x1 |
| Product Code | FEN |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-18 |
| Decision Date | 1995-07-06 |